sop for cleaning and operation of storage vessels
1.0 OBJECTIVE
1.1 To describe the cleaning and operation of storage vessels.
2.0 SCOPE
2.1 This procedure is applicable for storage vessels present in the production Liquid department.
3.0 RESPONSIBILITY
3.1 Operator – To perform the procedure.
3.2 Officer production- To ensure that the operation is being performed in compliance with the SOP.
3.3 IPQA person – To ensure in-process checks, and counter check that the
Compliance is in line with SOP.
4.0 ACCOUNTABILITY
4.1 Department Head
5.0 PROCEDURE
5.1 Cleaning: Type A procedure (Batch to Batch Cleaning)
5.1.1 Ensure all the material is removed from the equipment.
5.1.2 Remove the product status label and affix ‘To be cleaned’ status label as per sop over the equipment.
5.1.3 Type A cleaning applicable for batch to batch cleaning of same strength, color, and flavor and continuous seven batches.
5.1.4 Type A cleaning applicable for shift end cleaning.
5.1.5 Check and ensure the cleanliness and availability of accessories used for cleaning Nylon brush, Nylon scrubber, Lint free cloth, Gloves.
5.1.6 Apply potable water with pressure on the inner and outer surface of the vessels to remove the adhered material and open the outlet valve with connection to drain through PVC pipe.
5.1.7 Open the lid and fill the vessel with approx 300 lit of potable water through pipe.
5.1.8 Above potable water circulated through high pressure pump & spray valve for 5 minutes.
5.1.9 Open the outlet valve of the vessel and let the water drain through it.
5.1.10 Repeat the process twice, finally rinse with 40-50 lit of purified water.
5.1.11 Cleaning operation should be supervised by Production officer & necessary records should be maintained.
5.2 Cleaning: Type B procedure
5.2.1 Ensure all the material is removed from the equipment.
5.2.2 Remove the product status label and affix ‘To be cleaned’ status label as per sop over the equipment.
5.2.3 Check and ensure the cleanliness and availability of accessories used for cleaning Nylon brush, Nylon scrubber, Lint free cloth, Gloves.
5.2.4 After continue five batches, Type B cleaning should be performed.
5.2.5 Open the lid & approx 300 lit of potable water in the vessel through pipe.
5.2.6 Above potable water circulated through high pressure pump & spray valve for 15 minutes.
5.2.7 Open the outlet valve of the vessel and let the water drain through it. Repeat the process twice.
5.2.8 Take 100 liters hot purified water (80 to 85oc) circulated through high pressure pump & spray valve for 10 minutes for sanitization of vessel.
5.2.9 Open the outlet valve of the vessel and let the water drain through it.
5.2.10 Inform IPQA officer to the sample of rinse water to QC for wash water analysis.
5.2.11 After getting the approval of QC, affix “Cleaned Label” as per sop take the fresh batch manufacturing as and when required.
5.2.12 Cleaning operation should be supervised by Production officer & necessary records should be maintained.
5.2.13 Type B Cleaning Valid For 72 Hours.
5.2.14 Type B cleaning should be performing after maintenance of any contact parts.
5.3 OPERATION
5.3.1 Ensure the surrounding areas are cleaned before starting operation.
5.3.2 Switch ON the main.
5.3.3 Push green button to start the operation.
5.3.4 Filling and sealing should be completed in 72 hours after filtration/colloid. If not completed in 72 hours inform IPQA to collect and send bulk sample to QC for analysis.
5.3.5 Then Filling and sealing should be starts After QC approval.
5.3.6 Start the stirrer with 100 rpm in filling and sealing of suspension continue till stirrer dipped in solution. After that start recirculation.
5.3.7 Push red button to stop the operation.
6.0 TRAINING
6.1 Trainer: Department Head.
6.2 Trainee: Production, Quality Assurance and Operator person.
6.3 Period: one hour or as per required.
7.0 DISTRIBUTION
7.1 One set of Master copy and one set of Controlled copy submit the QA department.
8.0 ENCLOSURES
8.1 NIL
9.0 ABBREVIATIONS
9.1 IPQA : In-process Quality assurance
9.2 BMR : Batch manufacturing record.
9.3 SOP : Standard operating Procedure.
9.4 QC : Quality Control
9.5 QA : Quality assurance
10.0 DOCUMENT CHANGE HISTORY
| Revision | Reason for revision | Effective Date
|
| 00 | NEW SOP |
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